The Effect of Warm Application to the Breast With the Aid of Thera Pearl on Milk Release and Breastfeeding Success

NCT05806892 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2023-07-19

No results posted yet for this study

Summary

Breastfeeding and breast milk are very important in supporting newborn growth and development. The World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) recommend that breastfeeding should be continued with only breast milk for the first 6 months after birth and with complementary foods until the age of 2 years. However, the rate of breastfeeding all over the world is far from the targeted values. For this reason, it is necessary to plan and implement various interventions in order to start breastfeeding in the early period and to help maintain breastfeeding.

There are various problems associated with breastfeeding. Large, sunken or flat nipples, tongue-tie in the fetus, excessive milk production, lack of milk production or late onset are some of these problems. It is known that the most common problems are breast fullness or late onset of milk production. In both cases, early resolution is important in ensuring the sustainability of breastfeeding. During the breastfeeding period, various applications are used in order to both relieve fullness and increase milk production. Applying hot water to the udder is the most preferred way to increase milk production. The fact that it does not require much cost, does not contain any herbal or pharmacological agents and is easy to apply, as well as relieving the fullness of the breasts for the mother and increasing milk production, increases the popularity of hot water application. When the relevant literature was reviewed, it was seen that the hot application to the breast was generally done through a warm towel or hot water bag, but there was no study using Thera Pearl.

This study will be carried out in an experimental design in order to evaluate the effect of warm application applied to the breast with the help of Thera Pearl in the postpartum period on milk release, breastfeeding success of mothers, milk perception and postpartum breastfeeding self-efficacy. The research will be carried out in Amasya University Sabuncuoğlu Şerefeddin Training and Research Hospital obstetrics service between April and September 2023. Personal Information Form, Breastfeeding Observation Form, Bristol Breastfeeding Evaluation Scale, Breastfeeding Self-Efficacy Scale and Insufficient Milk Perception Scale will be used to collect data. It is thought that the application to be made for breastfeeding problems and milk release will be effective.

Conditions

  • Breast Feeding

Interventions

OTHER

Thera Pearl

You can apply Thera°Pearl warm breast therapy before breastfeeding or during milking. You should do this application 4 times a day, in the morning, at noon, in the evening and at night before going to bed. Each application should be done on both breasts and should last at least 20 minutes. Thera°Pearl Warm Breast Therapy has been developed to open milk ducts and accelerate milk flow. Thermogel packs for Thera°Pearl hot therapy can be heated inside the fabric covers in the microwave for a maximum of 15 seconds or in hot water by removing the fabric covers. Packages that have been removed from the cover should be kept in boiling water for 1-2 minutes and then applied by putting them into the sheath.

Sponsors & Collaborators

  • Ataturk University

    collaborator OTHER
  • Amasya University

    lead OTHER

Principal Investigators

  • Hava Özkan, Özkan · Ataturk University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-24
Primary Completion
2023-08-31
Completion
2023-09-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05806892 on ClinicalTrials.gov